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PATH Study: Informing Proposed FDA Tobacco Product Standards

May 12, 2022

The U.S. Food and Drug Administration (FDA) has announced two proposed product standards: one to prohibit menthol as a characterizing flavor in cigarettes and one to prohibit all characterizing flavors (other than tobacco) in cigars. The goal is to significantly reduce disease and death from combusted tobacco product use by reducing addiction and youth experimentation, increasing the number of smokers that quit, and advancing health equity by addressing key health disparities.

Findings from the Population Assessment of Tobacco and Health (PATH) Study, conducted by Westat in support of FDA’s regulatory actions, are cited in each standard and serve as critical guideposts in FDA’s mission to reduce the public health burden of tobacco through its regulations. The standards cite 13 peer-reviewed scientific papers to which Westat’s tobacco regulatory scientists contributed as authors within the PATH Study, plus another 15 papers written by outside researchers using PATH Study data. Additional internal FDA scientific reviews employing PATH Study data are also referenced.

In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the U.S., with particularly high rates of use by youth, young adults, and African American and other racial and ethnic groups. Published modeling studies using PATH Study data have estimated a 15% reduction in smoking within 40 years if menthol cigarettes were no longer available in the United States. These studies also estimate that 324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided over the course of 40 years.

Characterizing flavors in cigars, such as strawberry, grape, cocoa and fruit punch, increase appeal and make cigars easier to use, particularly among youth and young adults. According to PATH Study data, for the majority of youth cigar smokers, the first cigar they tried was flavored. Among young adults, the majority of cigar uses say that flavoring is a reason for cigar use.

As stated by the FDA, the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of these products and build on the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterizing flavors (other than tobacco and menthol) in cigarettes in 2009. For more information on the proposed standards, and follow-up actions, see the FDA’s Center for Tobacco Products web page.

Learn more about the PATH Study:

Population Assessment of Tobacco and Health (PATH) Study
FDA and NIH Study: Population Assessment of Tobacco and Health
Using the PATH Study to see how regulating tobacco products affects behavior and health

Read the official announcement of the proposed standards:

Tobacco Product Standard for Menthol in Cigarettes
Tobacco Product Standard for Characterizing Flavors in Cigars


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